Job Summary

Primary Role

Provide a brief summary describing the major role, responsibilities and purpose of the job.  Summarize key areas of accountability and budget responsibility, if applicable.

Under the direction of the Senior Director Medical Devices and Combination Products, the Global Clinical Development Lead (GCDL) Medical Device and Combination Products will be responsible to serve as the device clinical representative on assigned project teams, sub teams and corporate initiatives.

The candidate will have demonstrated ability to manage multiple programs, therapeutic areas and/or work streams with a high degree of complexity; advanced understanding of the device development, execution of clinical programs and clinical studies to support novel drug delivery devices and combination products.

In addition will have in-depth knowledge of global regulatory/industry rules and guidance’s (e.g. ICH, GCP, and labeling) to drive the strategic approach to medical device approval and clinical trial supporting documents development process. The Clinical Program Lead, Medical Devices is responsible for working closely cross-functionally with other global teams including Device Development, Quality Assurance, Clinical Operations, Global Regulatory, Drug Safety, Commercial, and Legal.

Essential Functions

Responsibilities

50% Oversight with an emphasis on strategic planning, implementation and execution program and work stream plans for therapeutic indications or company initiatives in keeping with corporate and department goals.

Represents medical devices and combination products perspective in the clinical sub-team of Global Product Teams (GPTs)Collaborates with GPT Lead, Global Clinical Development Lead, Medical Director to ensure that all development and product support activities for medical devices are coordinated and consistentReview and edit clinical protocols and clinical study reports ensuring accuracy of scientific, clinical, and medical contentSupport reviews and interpretation of clinical data to deliver meaningful efficacy and safety conclusionsDemonstrates the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholdersSupport and / or lead clinical / medical advisory panels, steering committees, and investigator meetingsSupport and / or lead safety review committees and risk management activities as appropriateParticipate in device and drug safety surveillance for development projectsParticipate in/or lead cross-functional teams in the development of clinical program deliverables including product labels, clinical trial training material, clinical and scientific summariesManage and present clinical safety data involving drug and device variablesEngage data management and biostatistics teams to collect and present clinical data summaries for cross functional reviewProvide update and direction to Sr. Management when conflicts, key developments and program scope/direction changes are identified.Effectively represent the interests and perspective of the Clinical Development Devices team

40% Assess skills and resources needed for success; work closely with internal and external stakeholders to leverage and optimize resources

Provide medical review for clinical evaluations and clinical summaries per regulations and in advance of filing submissions for new devices and combination productsProvide medical review and harm assessment for risk assessment activities for device and combination products across multiple therapeutic areasAssist in providing medical information support for marketed and development projectsLead or participate in internal and external medical writing resources to develop clinical summaries, clinical study reports, clinical evaluations, and pediatric assessments for submission to regulatory bodiesEngage with KOLs and PIs in peer to peer discussions to support clinical trials, advisory boards, and scientific exchange.Lead or participate in the development and maintenance of policy and SOPs designed to ensure alignment with regulations, guidance, and internal company requirementsLead or participate in the development of instructions for use, product administration guides, and similar training material including procurement and clinical oversight of artwork and administration stepsContributes to the clinical study design for medical devices and combination productsAssures clinical study design and data generated meets regulatory authority requirementsLeads safety review input for medical devices and combination productsAlign with team members from other functional areas regarding planning, implementation, tracking, analysis and report of milestonesProvide support to publication strategy for assigned projects / products assuring highest standards of science within product strategic needs and compliance requirements

5% Participate in business development and process improvement activities as needed

Under the direction of the Senior Director, Clinical Development Medical Device and Combination Products participate in due diligence activities and or department and/or corporate wide task forces as appropriate

5% Other activities as deemed by management

Participate in Research and Development, department and/or corporate wide task forces as appropriate

Education & Experience Requirements

M.D. degree At least (8-10) years of experience in the pharmaceutical, device or biotechnology field with relevant industry experienceClinical practice experience 3-4 years minimumDemonstrated ability to collaborate in a matrixed environmentExperience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authoritiesExperience with the Medical Device Regulation (MDR) and clinical evaluationsExperience in designing and conducting clinical trialsExperience with product development and design control in device and combination products

Key Skills and Competencies

Demonstrated ability to work on multiple programs and/or therapeutic areas associated with a high degree of complexity; known as effective resource for organization, execution, problem solving and influencing cross-functionally.Work closely with clinical development devices team comprised of clinicians and clinical program leaders.Ability to work closely with technical teams including device development engineers, human factors engineers, and device quality engineers.  Solid knowledge of device FDA, ICH, GCP, MDR guidelines.In depth knowledge and experience evaluating, and leading teams to evaluate, clinical literature, clinical summaries, clinical protocols, and materials that include clinical data and safety data in medical device and combination products.Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences.  Ability to act as company spokesperson or scientific witness as needed.

Other Job Components

Complexity and Problem Solving

Strong interpersonal skills and motivates individuals and teams towards achieving results.Requires ability to critically assess processes, identify opportunities and implement improvements while collaborating with other functional experts.Requires high degree of problem solving ability; understanding of objectives and processes across multiple organizational functions.

Internal and External Contacts

List contacts this job advises, consults and coordinates with on a regular basis.   Describe to whom this job is accountable.  Indicate each Contact Category (Internal, Vendor, Customer, or Other) and provide examples.

Internal interactions with Drug Clinical Development, Device Development, Medical Affairs, Program Management, Regulatory Affairs, Commercial, Legal, Quality, Compliance, and Drug Safety.External interactions with medical writing consultants, contract research organizations, core laboratories, investigators & investigation sites, patient organizations, KOLs and other stakeholders as identified.

Other Requirements

Availability to travel up to 25% of time.